- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07654049
Study of Teprenone in the Treatment of Glucocorticoid-Induced Drug-Related Gastrointestinal Injury
Objective:
To evaluate the efficacy, safety, and adherence of the gastric mucosal protective agent teprenone in the treatment of glucocorticoid-induced drug-related gastrointestinal injury.
Study Design:
This study is a prospective, open-label, randomized controlled trial. The study population consists of patients with systemic lupus erythematosus requiring medium- to high-dose glucocorticoid therapy (30-60 mg/day). Eligible patients are enrolled according to inclusion and exclusion criteria and randomly assigned in a 1:1 ratio into two groups: a proton pump inhibitor (PPI) group and a mucosal protective agent group. The PPI group receives omeprazole capsules 20 mg once daily before meals, while the mucosal protective agent group receives teprenone 50 mg three times daily after meals. Both groups are treated for 12 weeks.
Primary Endpoint:
To assess the improvement in the 7-point overall symptom scale from baseline to week 12.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Huaxiang Wu
- Telefonnummer: 0571-87783777
- E-post: wuhx8855@zju.edu.cn
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Age 18 to 70 years;
- Patients diagnosed with systemic lupus erythematosus (SLE) meeting the 2019 EULAR/ACR classification criteria for SLE;
- Receiving moderate to high doses of glucocorticoids (prednisone or its equivalent 30-60 mg , once daily);
- Voluntarily participate in this study and sign the informed consent form.
Exclusion Criteria:
- Presence of other gastric mucosal lesions, such as active ulcers, active bleeding, gastric cancer, gastric polyps, etc.;
- History of subtotal gastrectomy;
- History of endoscopic treatments, such as Endoscopic Submucosal Dissection (ESD) or Endoscopic Mucosal Resection (EMR);
- Significant psychiatric and behavioral abnormalities or mood disorders;
- History of clinically significant diseases, including: Chronic congestive heart failure (NYHA Class IV); History of echocardiography-confirmed ejection fraction (EF) < 30%; Myocardial infarction, acute coronary syndrome, viral myocarditis, or pulmonary embolism within 6 months; Coronary revascularization within 6 months; Severe arrhythmia requiring treatment with Class Ia or III antiarrhythmic drugs;History of sick sinus syndrome, Mobitz II and Complete Heart Block without a permanent pacemaker implanted; QTc interval≥480 ms on screening ECG;
- Laboratory abnormalities at screening as follows: Total bilirubin > 3 times ULN (Upper Limit of Normal); AST/ALT > 3 times ULN; Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m²;
- Currently receiving treatment (e.g., chemotherapy, radiotherapy, immunotherapy) for other malignancies;
- Pregnant or lactating women;
- Allergy or hypersensitivity to the study drug(s).
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Proton Pump Inhibitor (PPI) group
|
Omeprazole cap 20 mg, q.d.
|
|
Experimentell: Mucosal protectant group
|
Teprenone 50 mg, t.i.d.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Improvement in the 7-point Global Overall Symptom Scale (GOSS) at week 12
Tidsram: From enrollment to the end of treatment at 12 weeks
|
From enrollment to the end of treatment at 12 weeks
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Proportion of patients with a positive fecal occult blood test
Tidsram: At weeks 4, 8, and 12
|
At weeks 4, 8, and 12
|
|
changes in levels of hemoglobin
Tidsram: At weeks 4, 8, and 12.
|
At weeks 4, 8, and 12.
|
|
Changes in levels of fecal calprotectin
Tidsram: At weeks 4, 8, and 12
|
At weeks 4, 8, and 12
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Proportion of days covered by medication
Tidsram: From enrollment to the end of treatment at 12 weeks
|
The proportion of days covered is defined as the number of days with drug availability (without double-counting overlapping days) relative to the total number of days in the observation period
|
From enrollment to the end of treatment at 12 weeks
|
|
Incidence of adverse events and serious adverse events.
Tidsram: From enrollment to the end of treatment at 12 weeks
|
From enrollment to the end of treatment at 12 weeks
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- 2-pyridinylmetylsulfinylbensimidazol
- Sulfoxider
- Svavelföreningar
- Organiska kemikalier
- Pyridiner
- Heterocykliska föreningar, 1-ring
- Heterocykliska föreningar
- Bensimidazol
- Heterocykliska föreningar, 2-ring
- Heterocykliska föreningar, smältring
- Omeprazol
- geranylgeranylacetone
Andra studie-ID-nummer
- 2026-0322
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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